Cincinnati—For many people, the concept of participating in a clinical trial is intimidating, frightening and unappealing.
But University of Cincinnati (UC) physician-scientists will remind naysayers that anyone who takes a medication or has a medical treatment is able to do so because of clinical research. And that research was made possible because average people volunteered to participate in it.
Mary Mahoney, MD, says there are three common public misperceptions about clinical trials that cause people to shy away:
- Research trials are only for people have no other options,
- Patients are randomly experimented on “like guinea pigs,” and
- Some patients are denied treatment entirely
“One of the biggest myths out there is that clinical trials are only for people with no other choices,” says Mahoney, director of breast imaging at the UC Barrett Cancer Center at University Hospital and professor of radiology at UC. “There are clinical trials for every stage of disease as well as prevention and early detection—and they all have value.”
Through the Barrett Cancer Center, for example, Mahoney leads trials looking at the value of new diagnostic imaging tools such as ultrasound, magnetic resonance imaging (MRI) and digital mammography for detecting early stage breast cancer.
“Recent clinical trials led to the discovery that digital mammography detects cancers better in women with dense breast tissue and that one in 10 women with newly diagnosed cancer in one breast will develop the disease in the opposite breast, which can be detected earlier with breast MRI,” she explains. “Now lives are being saved every day because these tools are used during the standard diagnostic breast imaging for many women.”
Clinical trials are the last step in a carefully regulated, detailed scientific process that starts in a laboratory in cells or tissue and is then tested in humans—oftentimes years later and always after strenuous review.
Medical studies are supervised by a local physician and look at every stage of disease, from first diagnosis to advanced disease. All are designed to find, diagnose, treat or prevent cancer.
“Clinical trials exist to answer questions and allow us to learn better ways to treat specific diseases. It is the only way medicine can move forward,” says Michael Reed, MD, a UC associate professor and surgeon who specializes in treating lung cancer. “Every new drug must be studied to avoid unforeseen negative outcomes and avoid treatments that aren’t beneficial. Even though not everyone who participates in a clinical trial will receive the investigational therapy, everyone does get the same standard of care they would if they didn’t participate.”
There are four basic types of clinical trials:
- TREATMENT trials test a new approach to medical treatments such as surgery, radiation therapy and new medications as well as different combinations of existing treatment or new methods, such as gene therapy.
- PREVENTION trials seek to stop cancer from ever developing through the use of preventative vitamins, minerals or medications.
- SCREENING trials are aimed at finding cancer earlier through imaging or blood tests. The goal is to detect cancers in early stage development when they are typically more treatable.
- Quality of life/supportive care trials focus on ways of helping people with cancer deal with the complications of treatment—both mental and physical. These may include things like sexual desire or fatigue.
Before a patient is enrolled in a clinical trial, the individual is carefully screened against a set of criteria designed to create a group of people that are as similar as possible.
“Qualification depends on a variety of factors including stage of disease, existing health conditions and other factors. The criteria for each trial are very specific to avoid including anyone in a trial that doesn’t fit,” explains Alison Kastl, director of cancer clinical trials for the Barrett Cancer Center.
The patient then goes through what is known as “informed consent” where the goals of the trial, why it is needed and how it will work are explained in easily understandable terms.
“Patients should take the time to discuss all the details of a clinical trial with their doctor and family before agreeing to participate,” adds Kastl. “It is important to keep asking questions until the patient is 100 percent comfortable with their decision to participate.”
Those questions might include information about costs, time commitments, potential benefits as well as side effects. This may vary, based on where the new therapy or tool is in development and testing process (phases).
- Phase I and phase II trials focus primarily on safety of the new treatment. Phase I trials are investigational and therefore include a very small number of people—about 15 to 30 people. The goal is to determine safe medical dosage, the best method of delivery (for example, a pill or fluids) and potential side effects. Phase II trials seek to determine if a new therapy has a specific effect on a certain type of cancer in a slightly larger population group of less than 100 people.
- Phase III, IV andV trials focus on larger-scale testing to compare the investigational medical treatment to the standard of care and further assess its long-term safety and effectiveness. These trials may require a longer time commitment and more paper surveys.
Stringent patient protections implemented to ensure safety and ethical conduct are monitored by an Institutional Review Board (IRB), a governing committee made up of physicians, scientists and members of the community responsible for scientific review and approval of all clinical research studies. Other medical monitoring groups are in place to ensure medical oversight and ethical conduct throughout the clinical research process.
Reed says it is important to note that if a new drug or therapy doesn’t show enough benefit to the target population in the early stages of human testing, it does not move forward.
“The IRB is essentially a medical watchdog put in place to protect patients,” he explains. “They ensure that the medical risks are reasonable compared to the possible benefits of a clinical study.”
For more information on clinical trials, visit www.cancer.gov/clinicaltrials. To find a UC cancer clinical trial, visit www.uccancercenter.uc.edu/research/clinicaltrials.